Comprehensive Environmental Health and Safety Program—Pharmaceutical Industry Facility

Comprehensive, multi-faceted compliance services with close regulatory agency coordination brought the facility into compliance.

Landmark supported development and implementation of a comprehensive environmental health and safety program at a pharmaceutical facility that manufactures Schedule 1 narcotics. Services provided included personnel exposure assessment monitoring, ongoing process safety evaluations and a thorough regulatory status evaluation in: air, water, hazardous materials/waste, and safety compliance. This three-year project was performed during merger/acquisition of the facility and included improvements to the Facility Safety Manual and process health and safety protocols.

The facility’s classification was within an industry code required to obtain storm water discharge permits. Permitting exceptions were identified and close regulatory agency coordination brought the facility into compliance. Annual chemical inventories and reporting was streamlined. An Emergency Response Plan and training program were developed, and inventory control systems were established to readily enable identification of reportable quantities.

Based on the quantity of hazardous waste generated the facility was operated and classified as a large quantity generator (LQG). Wastes not considered hazardous were included in improved recycling programs. The facility was also located in an industrial area where soil and groundwater contamination was a key consideration during a planned expansion, and during this project air sampling was conducted during excavation activities to evaluate worker exposures.

Project Highlights

  • Safety programs for asbestos, lead in drinking water and lead-based paint (LBP) were efficiently developed.
  • Clean room environments were monitored for particulates, organic vapors and other chemical constituents.
  • Waste management by properly managing hazardous and solid waste from the time of generation to disposal, preparing Hazardous Waste Reports and annual Toxic Release Inventory Reports.
  • Contaminant exposure routes of entry for inhalation, ingestion and dermal contact were evaluated and Action Levels were identified.
  • Personal protective equipment (PPE) programs were developed to minimize the risk of employee exposure based on assessed exposure potential.
  • Developed worker and equipment decontamination procedures, provided pragmatic recommendations for engineering controls.
  • Field screening of soils excavated during facility construction was performed to support EPA Innocent Landowner determinations and to confirm remaining contaminants.